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A Japanese multicenter phase II study of adjuvant chemotherapy with mFOLFOX6/CAPOX for stage III colon cancer treatment after D2/D3 lymphadenectomy

  • Kazuhiko Yoshimatsu
  • Keiichiro Ishibashi
  • Keiji Koda
  • Hajime Yokomizo
  • Noritaka Oda
  • Mitsuru Oshiro
  • Hiroyuki Kato
  • Masatoshi Oya
  • Hideo Nakajima
  • Shinji Ooki
  • Hiroshi Maekawa
  • Toshio Matsunami
  • Masahiro Tsubaki
  • Takeshi Yamada
  • Michiya Kobayashi
  • Kohji Tanakaya
  • Masaru Yokoyama
  • Hideyuki IshidaEmail author
Original Article
  • 76 Downloads

Abstract

Purpose

A phase II trial was conducted to investigate the benefit of oxaliplatin-based adjuvant chemotherapy in Japanese stage III colon cancer patients.

Methods

Eligible patients were scheduled to receive 12 cycles of mFOLFOX6 or 8 cycles of CAPOX in adjuvant settings. The primary endpoint was the 3-year disease-free survival (DFS). Cox proportional hazards regression was performed to identify risk factors for a worse DFS.

Results

A total of 130 patients, including 73 patients receiving mFOLFOX6 and 57 patients receiving CAPOX, were enrolled from 16 institutions between April 2010 and April 2014. The 3-year DFS was 82.2%, exceeding the expected primary endpoint of 81.7%. The 3-year DFS tended to be higher in patients receiving mFOLOFOX6 than in those receiving CAPOX (mFOLFOX6, 86.3%; CAPOX, 76.9%; P = 0.06). The 3-year DFS rates did not differ markedly based on the risk stratification (T1/T2/T3 N1 vs. T4 or N2) indicated by the IDEA COLLABORATION study (P = 0.22). In the multivariate analysis, stage IIIC (P = 0.046) and early discontinuation (P < 0.01) were identified as independent significant risk factors for a worse DFS.

Conclusion

Our findings represent the first positive results in a Japanese phase II trial of adjuvant chemotherapy with mFOLFOX6/CAPOX. Early discontinuation within 2 months was an independent risk factor for a shorter DFS.

Keywords

Stage III colon cancer Adjuvant chemotherapy mFOLFOX6 CAPOX Early discontinuation 

Notes

Acknowledgements

We appreciate the help of Dr. Tomoyuki Kawada in supervising the biostatistical analysis. We also thank Drs. Nobuhiro Takiguchi, Shigehisa Mori, Hisato Osada, and Noboru Oriuchi for their useful advice.

Compliance with ethical standards

Conflict of interest

Keiichiro Ishibashi, Hiroyuki Kato, Michiya Kobayashi and Hideyuki Ishida received a research grant from Yakult Co., Ltd. and Chugai Pharmaceutical Co., Ltd. Masatoshi Oya received a research grant from Yakult Co., Ltd., and Hiroshi Maekawa received a research grant from Chugai Pharmaceutical Co., Ltd. The other authors have no conflicts of interest to declare.

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Copyright information

© Springer Nature Singapore Pte Ltd. 2019

Authors and Affiliations

  • Kazuhiko Yoshimatsu
    • 1
  • Keiichiro Ishibashi
    • 2
  • Keiji Koda
    • 3
  • Hajime Yokomizo
    • 1
  • Noritaka Oda
    • 4
  • Mitsuru Oshiro
    • 5
  • Hiroyuki Kato
    • 6
  • Masatoshi Oya
    • 7
  • Hideo Nakajima
    • 8
  • Shinji Ooki
    • 9
  • Hiroshi Maekawa
    • 10
  • Toshio Matsunami
    • 11
  • Masahiro Tsubaki
    • 12
  • Takeshi Yamada
    • 13
  • Michiya Kobayashi
    • 14
  • Kohji Tanakaya
    • 15
  • Masaru Yokoyama
    • 16
  • Hideyuki Ishida
    • 2
    Email author
  1. 1.Department of Surgery, Medical Center EastTokyo Women’s Medical UniversityTokyoJapan
  2. 2.Department of Digestive Tract and General Surgery, Saitama Medical CenterSaitama Medical UniversityKawagoeJapan
  3. 3.Department of SurgeryTeikyo University Chiba Medical CenterIchiharaJapan
  4. 4.Department of SurgeryMatsuda HospitalUkiJapan
  5. 5.Department of Surgery, Sakura Medical Center, School of Medicine, Faculty of MedicineToho UniversityTokyoJapan
  6. 6.First Department of SurgeryDokkyo Medical UniversityMibuJapan
  7. 7.Department of Surgery, Saitama Medical CenterDokkyo University School of MedicineMibuJapan
  8. 8.Department of OncologyAgeo Central General HospitalAgeoJapan
  9. 9.Department of Organ Regulatory SurgeryFukushima Medical UniversityFukushimaJapan
  10. 10.Department of SurgeryJuntendo University Shizuoka HospitalNagaokaJapan
  11. 11.Department of PharmacyKanazawa Red Cross HospitalKanazawaJapan
  12. 12.Department of SurgeryYuai Memorial HospitalKogaJapan
  13. 13.Department of Gastrointestinal and Hepato-Biliary-Pancreatic SurgeryNippon Medical SchoolTokyoJapan
  14. 14.Cancer Treatment CenterKochi Medical School HospitalNankokuJapan
  15. 15.Department of SurgeryIwakuni Clinical CenterIwakuniJapan
  16. 16.Department of SurgeryHigashimatsuyama Medical Association HospitalHigashimatsuyamaJapan

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